Cleared Traditional

K011393 - RANDOX PHENYTOIN

K011393 is an FDA 510(k) clearance for RANDOX PHENYTOIN, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Toxicology device with product code DIP cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K011393 · Randox Laboratories, Ltd. · Toxicology device
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Dec 2001
Decision
211d
Days
Class 2
Risk

K011393 is an FDA 510(k) clearance for the RANDOX PHENYTOIN. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on December 4, 2001 after a review of 211 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K011393

510(k) Number K011393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date December 04, 2001
Days to Decision 211 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 87d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIP Device Classification - Class 2, Special Controls

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DIP Enzyme Immunoassay, Diphenylhydantoin

All 39
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K011393.
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